Z-0692-2020 Class III Terminated
FDA device recall Z-0692-2020 was initiated by Ameditech Inc on February 15, 2019 and is designated Class III. Reason for recall: Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere iScreen Drugs of Abuse Dip Test (P/N X11-IS10-22015-DX LOT #188744) The recall status is terminated (terminated April 28, 2021). Affected quantity: 3400 units (136 kits).
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2019
- Initiation Date
- February 15, 2019
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3400 units (136 kits)
Product Description
QuickTox 5 Panel Drug Screen DipCard
Reason for Recall
Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere iScreen Drugs of Abuse Dip Test (P/N X11-IS10-22015-DX LOT #188744)
Distribution Pattern
US - AZ, CA, FL, GA, KS, LA, MI, MO, MS, NC, OK, TN, and TX. OUS - None
Code Information
Catalog Number: QT11 Lot Number: 188787